the hindu · 2020. 10. 19. · acknowledgements take this opportunity to express my gratitude to...

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ABSTRACT

ndia is home to 2.68 crore persons with disabilities comprising 2.21 per cent of its

population (2011 Census). However, less than 16 per cent of persons with disabilities have

any assistive aids and appliances. In general, Indian innovators in assistive device

technology lack crucial understanding of the market realities and possess a sketchy understanding

of issues that have important implications for the disability sector. This has resulted in poor

research and engineering of assistive devices, directly affecting the quality of support given to

the disabled.

Some of the issues that have not been fully understood by Indian innovators are: ‘freedom-to-

operate’ and consequent infringement of Intellectual Property Rights (IPR), the necessity to

comply with regulatory and industry standards, and the need for robustness, precision, accuracy,

and reliability. As cost-effective environmental interventions have not been effectively

implemented in India, and because distribution of aids and assistive devices are not effectively

funded by the government, almost two thirds of those using assistive devices and rehabilitation

technology have purchased the devices themselves from private sources.

Those left without assistive devices, or with old-fashioned and inefficient devices are the target for

those who enter the market with ‘low cost’ devices, of dubious scientific or medical value, and

poor regulatory compliance. As an under-served and under-supported sector, the assistive devices

sector only benefits from innovations by those innovators who have spotted the niche funding

opportunity and lack of robust competition in the so-called low cost indigenous market.

Three recent legal instruments have the potential to significantly improve the access of good

quality assistive devices for the disabled India. The instruments, arriving nearly together, set up

formidable barriers to poor research and engineering, and non-standard assistive devices being

distributed to unwary persons with disability who are in want and discomfort. These are The Rights

of Persons with Disability Act, 2016, The Medical Devices Rules, 2017 and The National Ethical

Guidelines for Biomedical and Health Research Involving Human Participants, 2017.

This Policy Report takes stock of the compliance and regulatory environment in India, critically

examines the legal ecosystem relating to research and ethics of clinical trials for assistive devices.

It also analyses the gaps in the ethical conduct of research and concludes by highlighting the need

to streamline research protocols in order to serve the disability sector in an effective manner.

I

TABLE OF CONTENTS

I Disability in India – A Statistical Perspective 1

II Clinical Trial of Medical Devices in India 17

III The Legal Ecosystem for Research 31

IV Analysis of Gaps in Ethical Conduct of Research

46

V Streamlining Research in Rehabilitation and Assistive Technologies

55

VI Glossary of Terms 71

VII Acts and Rules 79

ACKNOWLEDGEMENTS

take this opportunity to express my gratitude to The Hindu Centre for Politics and Public

Policy for accepting my proposal and supporting this study. In particular, I wish to thank

V.S. Sambandan, Saptarshi Bhattacharya, and Vidya Subramaniam for their guidance and

editorial inputs. C. Ranganathan and P.V. Lakshminarasimhan were generous with their time in

ensuring comfort and timely processing of requests. For this, I thank them. The Centre also

ensured that we were able to meet and discuss our projects with experts in the areas of data

management and social science research, which helped refine my understanding.

Alamu, Mudasir, Grace, Osama, Girija Shankar and Kanika, helped create a real and valued

fellowship, rich in creative interaction and based on mutual respect. I thank them for their many

suggestions, perspectives and ideas, and wish them great success.

I would be failing in my duty, if I didn’t thank Hariprasad Karnam, my colleague and COO at

IP DOME, for his support on the data gathering, analysis and visualisation. My husband,

P.V.S. Giridhar, provided significant legal insights for which I am grateful.

My experience as the Member – Legal of several Institutional Human Ethics Committees including

those of IIT-Madras, National Institute of Epidemiology - ICMR, SRM Institute of Medical

Sciences, SRM Medical College, and National Institute of Siddha, helped me develop and refine

my understanding of the role of research in improving the lives of people, and the importance of

regulatory standards and compliances with legal requirements in the conduct and monitoring of

such research. For this, I wish to express my thanks and also my appreciation for the commitment

demonstrated by the members of these committees towards ethical conduct of research.

I

Bridging Multiple Gaps: Strengthening India’s Research Protocols for Assistive Aids

1

I. DISABILITY IN INDIA – A STATISTICAL PERSPECTIVE

tatistics regarding the prevalence of disabilities vary widely depending on the reliability of

statistics and the difference in the manner of collection of the data. According to the

World Health Organisation’s World Report on Disability1, 15 per cent—about one billion

people—of the world’s population lives with some form of disability of whom, 2-4 per cent

experience significant difficulties in functioning. The Global Burden of Disease that assesses

mortality and disability estimates a figure of around 19.4 per cent2 of the global population as

having disabilities, and around 3.8 per cent having severe disability. All reports agree that the global

estimate for disability is witnessing a rise due to populations ageing and the rapid spread of chronic

diseases, as well as improvements in methodologies used to measure disabilities.

The World Report on Disability also states that disability disproportionately affects vulnerable

populations. Results from the World Health Survey indicate a higher disability prevalence in lower

income countries and people from the poorest wealth quintile; women and older people also have

a higher prevalence of disability. Multiple Indicator Cluster Surveys in selected countries show that

children from poorer households and those in ethnic minority groups are at significantly higher

risk of disability than other children. Increasing evidence suggests that people with disabilities

experience poorer levels of health than the general population and may experience greater

vulnerability to preventable secondary conditions, co-morbidities, and age-related conditions. In

many low-income and middle-income countries, only 5-15 per cent of people who require assistive

devices and technologies have access to them3. Mukesh Jain, Joint Secretary, Department of

Disability Affairs, Government of India, stated that prevalence of disability was much higher in

rural areas than in urban areas, among men more than women, and that movement disability was

the most significant4 disability.

1 World Health Organization. 2011. “World Report on Disability”. [http://apps.who.int/iris/bitstream/handle/10665/70670/WHO_NMH_VIP_11.01_eng.pdf;jsessionid=57DF2CEDE69819B128C1F1457A6B01CC?sequence=1]. 2 Herricks. J. R. et al. 2017. “The global burden of disease study 2013: What does it mean for the NTDs?”, PLoS Negl Trop Dis, August 3. Vol. 11, Issue. 8. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5542388/]. 3 World Health Organization. 2018. “Disability - Assistive devices and technologies”. [http://www.who.int/disabilities/technology/en/]. 4 Healthcare Innovation. 2015. “India needs assistive technologies for people with disabilities”, February 18. [https://www.enterpriseinnovation.net/article/india-needs-assistive-technologies-people-disabilities-390330408].

S

http://apps.who.int/iris/bitstream/handle/10665/70670/WHO_NMH_VIP_11.01_eng.pdf;jsessionid=57DF2CEDE69819B128C1F1457A6B01CC?sequence=1https://www.who.int/disabilities/technology/en/https://www.enterpriseinnovation.net/article/india-needs-assistive-technologies-people-disabilities-390330408

POLICY REPORT NO. 26

Source: http://www.healthdata.org/india

Data from the Global Health Data Exchange5 list some of the significant disabling conditions that

are not assessed as disability in India.

The lack of rigorous and comparable data on disability and evidence on programmes that work,

impede understanding and action in India. The latest and most definitive statistics from India on

the number of persons with disabilities is the 2011 census, which points out that 2.68 Crore

persons, amounting to 2.21 per cent of the population, are disabled6. However, the World Bank

report, People with Disabilities in India: From Commitments to Outcomes7, July 2009, prepared at the

request of the Government of India, estimated that people with disabilities comprised between

five and eight per cent of the Indian population (around 55-90 million individuals at that time).

The report found that only about 20 per cent of persons with disabilities in the National Sample

Survey’s 58th Round had ever been advised aids and appliances and less than 16 per cent had

acquired any such aids and appliances. Women with disability are less likely to receive aids and

appliances.

5 Institute for Health Metrics and Evaluation, University of Washington. 2018. “Global Health Data Exchange”. [http://ghdx.healthdata.org/]. 6 Social Statistics Division, Ministry of Statistics and programme Implementation, Government of India. “Disabled Persons in India, a statistical profile 2016”. [http://mospi.nic.in/sites/default/files/publication_reports/Disabled_persons_in_India_2016.pdf]. 7 The World Bank. 2009. “People with Disabilities in India: From Commitments to Outcomes”, July. [http://documents.worldbank.org/curated/en/577801468259486686/pdf/502090WP0Peopl1Box0342042B01PUBLIC1.pdf].

http://ghdx.healthdata.org/http://ghdx.healthdata.org/http://mospi.nic.in/sites/default/files/publication_reports/Disabled_persons_in_India_2016.pdfhttps://www.thehinducentre.com/publications/policy-report/article25781250.ece/binary/people%20with%20disabilities%20in%20India.pdf


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Persons with disability routinely report several barriers and challenges to good quality of life,

including inadequate policies and standards, and poor implementation and enforcement of existing

polices and standards. Beliefs and prejudices constitute barriers to education, health care, and social

participation. Misconception by employers that people with disabilities are less productive and that

reasonable accommodation is expensive for employers limits employment opportunities. The

World Report on Disability8 found that high cost and lack of provision of services near them were

the most frequent reasons for people with disabilities not using health facilities in Tamil Nadu.

Additionally, poor coordination of services, inadequate staffing, and weak staff competencies

negatively affect quality, accessibility, and adequacy of services.

The lack of effective financing is also a major obstacle to sustainable services in low- and middle-

income countries. Built environments remain inaccessible and lack of access to transportation is a

frequent reason for persons with disability being discouraged from seeking work or prevented

from accessing health care. People with disabilities have significantly lower rates of information

and communication technology use than non-disabled people, and in some cases, they may be

unable to access even basic products and services such as telephones, television, and the Internet.9

Often, many people with disabilities are excluded from decision-making in matters directly

affecting their lives.

All these factors impact their participation in clinical trials and research. Inability to access standard

health care may encourage them to participate in trials where they are assured of better standard

of care; inability to exercise autonomous decision-making capacity with regard to participation

may force them into participating involuntarily or discourage them from a potentially beneficial

clinical trial.

Cultural Perspective of Disability

Claims are made that Indian heritage viewed persons with disability as a part of and contributing

members of the larger society in the early centuries of the Common Era. Records claim that there

were workshops set up for persons with disabilities during the Gupta Period10. Kautilya is reported

8 World Health Organization. 2011. “World Report on Disability”, pg. 63. [http://www.who.int/disabilities/world_report/2011/report.pdf?ua=1]. 9 World Health Organization. 2011. “World Report on Disability”. [http://www.who.int/disabilities/world_report/2011/accessible_en.pdf]. 10 Narayan, J. 2004. “Persons with Disabilities in India: A Special Educator's Personal Perspective”, Disability Studies Quarterly, Spring 2004, Vol. 24, Issue. 2. [http://dsq-sds.org/article/view/485/662].

https://www.who.int/disabilities/world_report/2011/report.pdf?ua=1https://www.who.int/disabilities/world_report/2011/accessible_en.pdfhttp://dsq-sds.org/article/view/485/662


to have advised rulers that the indigent and persons with disabilities must be maintained at state

expense; Emperor Ashoka is said to have provided maintenance to persons of inadequate means,

widows and persons with disability11. Rulers, philosophers and poets with disabilities are said to

have been accepted in society since they are remembered in the epics (the visually impaired

Dhritarashtra of Mahabharata), and their works—Surdas, the poet, was visually impaired. Indian

religions taught that service for persons with disability granted punya; for those without disability,

disability in society offers a chance to develop charity and good karma for the next life. However,

as A.L. Basham points out, persons with disability in our epics are associated with acts of mischief

(Shakuni in the Mahabharata), having mala fide intentions (Manthara, the maid of Kaikeyi), or are

incompetent and undeserving (Dhritarashtra)12. Kautilya also was a forerunner in employing

dwarves, hunchbacked persons, and persons with deformities as spies and informers13.

In India, culturally driven negative attitudes towards disability in general and persons with disability

in particular have adversely impacted the development of rehabilitation engineering and assistive

devices. Hindus believe that, according to the law of karma, disability is a punishment for past

misdeeds14. Households with persons with disabilities also consider themselves punished.

However, this primary negativity is sustained and enhanced by social and economic factors, such

as the catastrophic and impoverishing impact of out-of-pocket health expenditures even in non-

disabled lower income households. Improving quality of life for persons with disability and

enhancing their participation was not encouraged in Indian culture. The first regular school for the

visually impaired was established in Amritsar in 1887 by Annie Sharp. The school continues to

function in its Dehradun premises where they shifted in 1902. The first and oldest formal school

for the hearing impaired was established in Bombay in 1885 by an association of liberals and the

philanthropist Vicar Apostolic, Dr. Leo Meurin15.

The ambiguity of Indian society towards acceptance of persons with disabilities as part of human

diversity persists. As recently as on December 27, 2015, the Prime Minister, in his monthly address,

11 “Social and Political Philosophy of The Welfare of The Disabled in India, Chapter – III”. [http://shodhganga.inflibnet.ac.in/bitstream/10603/84924/14/14_chapter-iii.pdf]. 12 Basham, A. L. 1924. “The Wonder that was India, London”, Sedgwick and Jackson Press. 13 ‘…servants such as have taken the appearance of a hump-backed person, a dwarf, a pigmy (kirata), the dumb, the deaf, the idiot, the blind…shall espy the private character of these officers…’ Full Text of Kautilya’s Arthasastra, [https://archive.org/stream/in.ernet.dli.2015.276669/2015.276669.Kautilyas-Arthasastra_djvu.txt]. 14 Gupta, V.B. 2011. “How Hindus Cope with Disability”, Journal of Religion, Disability and Health”, Vol. 15, Issue. 1. [https://www.tandfonline.com/doi/citedby/10.1080/15228967.2011.540897?scroll=top&needAccess=true]. 15 Disability Status – India. 2003. “Hearing Impairment”. [http://www.rehabcouncil.nic.in/writereaddata/HI-2-2003.pdf].

http://shodhganga.inflibnet.ac.in/bitstream/10603/84924/14/14_chapter-iii.pdfhttps://archive.org/stream/in.ernet.dli.2015.276669/2015.276669.Kautilyas-Arthasastra_djvu.txthttps://www.tandfonline.com/doi/citedby/10.1080/15228967.2011.540897?scroll=top&needAccess=true&https://www.thehinducentre.com/publications/policy-report/article25772293.ece/binary/HI-2-2003.pdf


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Mann Ki Baat¸ advocated the use of Divyaang—persons having some divine abilities in their limbs—

in place of Viklaang—maimed or crippled. Several organisations, including the National Platform

for the Rights of the Disabled, objected to the new terminology16 stating that the use of such

patronising terms would not lead to any change in the lives of the people. It would not address the

stigma and discrimination they face and the marginalisation they encounter. Again, the attribution

of divinity would not address issues of equality and dignity; on the contrary, it would tend to create

myths and further exclusion.

The social stratification in India, purportedly based on birth and, in turn, bound by the law of

Karma, accommodates persons with disability at a lower level of the ladder to moksha than others

on the same social hierarchy without disability. It is presumed that persons with disability are in

perpetual misery and pain as they repair their karma. They can rest happy in the knowledge that in

their next life they will be whole and happy. Unfortunately, this absurd and unproved (and

unprovable) line of reasoning seems to have made itself at home even in scientific institutions. The

Society for Biomedical Technology (SBMT), a collaboration between the Defence Research and

Development Organisation (DRDO), the Department of Rural Development, and Ministry of

Welfare, is a vehicle to provide indigenous solutions in the field of medical and healthcare

equipment and devices using spin off technologies from defence R&D. The founder-chairman of

SBMT is the late former President, A.P.J. Abdul Kalam, whose statement ‘Let my brain relieve

your pain’, is emblazoned on the banner of the website17. The statement, a part of his ‘Oath for

Doctors18’, is rife with presumption and innuendo—in particular the implication that those in need

of care are constantly in pain waiting to be relieved—the healthcare equivalent of the patriarchal

trope of damsel in distress.

This belief is incomprehensible to persons who have not encountered it in their formative years.

Writing about her experience in Cambodia, a country that also believes in karmic outcomes, Megan

Smith, a volunteer for UNICEF’s Local Governance for Child Rights programme, believes that

the difficulties and prejudices she faces are not due to her disability but due to a society that is not

16 National Platform for the Rights of the Disabled. 2016. “Copy of a letter addressed to Prime Minister Shri Narendra Modi”, January 22. [http://feministlawarchives.pldindia.org/wp-content/uploads/Letter-to-PM-by-National-Platform-for-the-Rights-of-the-Disabled.pdf]. 17 Society for BioMedical Technology. 2007. “A brief details of the projects undertaken by SBMT”. [http://www.sbmtindia.org/activities/]. 18 abdulkalam.com. 2001-16. “Oath for doctors”. [http://www.abdulkalam.com/kalam/theme/jsp/oath/oath_doctors.jsp].

http://feministlawarchives.pldindia.org/wp-content/uploads/Letter-to-PM-by-National-Platform-for-the-Rights-of-the-Disabled.pdfhttp://feministlawarchives.pldindia.org/wp-content/uploads/Letter-to-PM-by-National-Platform-for-the-Rights-of-the-Disabled.pdfhttp://www.sbmtindia.org/activities/http://www.abdulkalam.com/kalam/theme/jsp/oath/oath_doctors.jsp


accessible19. She is appalled by the commitment to suffering and acceptance of an inequitable

society by Cambodians with disability. Social culture promotes the perception that persons with

disability are in a perpetual state of misery and pain and that it is their rightful and natural condition.

Unfortunately, finding themselves at the receiving end, some Indians with disability are also in

alignment with the thought and prefer acceptance as a way to building better karma. They also

accept life as objects of pity and charity.

Studies have shown that sadness and misery are as prevalent in persons without disability as in

persons with disability. The Hedonic Adaptation theory20 states that regardless of what happens

to someone (winning a lottery/losing a limb), their level of happiness with return to their baseline

after the event. The baseline is individualised and individual differences in rates and extent of

adaptation are significant. There are internal circumstances under a person’s voluntary control

which, if altered, could lead to a different baseline of happiness. Attempts have also been made to

explain happiness as a state of surplus energy21 through association with good metabolism and

glucose levels, social support, goal achievement, social support and wealth, and respect for human

rights in the country where the person is resident. In fact, the level of pain or misery persons with

disability undergo in India is directly attributable to the stigma and marginalisation they encounter

in accessing necessary health care and rehabilitation support, and an inaccessible environment,

exacerbated with scant respect for human rights or for the person.

The foregoing is important to understand why persons with charitable intentions and poor

scientific capabilities, compounded by their almost arrogant non-compliance of known scientific

and legal regulatory mechanisms enter the field of rehabilitation engineering and assistive devices.

Since cost-effective environmental interventions have not been effectively implemented in India,

and because distribution of aids and assistive devices are not effectively funded by the government,

almost two-thirds of those using assistive devices and rehabilitation technology have purchased

the devices themselves from private sources. The assistance to buy aids and appliances fall within

a range of individual beneficiary schemes that have serious implementation problems and low

coverage. In addition, systems for support and maintenance of assistive devices remain under-

19 Smith, M. 2015. “Disabling karma: Reflections on Buddhism, disability and charitable drive-bys”, UNICEF, December 3. [https://blogs.unicef.org/blog/disabling-karma-reflections-on-buddhism-disability-and-charitable-drive-bys/]. 20 First explained by Brickman and Campbell in, Hedonic Relativism and Planning the Good Society, (1971). In M. H. Appley (Ed.), Adaptation-level theory (pp. 287-305). New York: Academic Press. 21 Gailliot, M. T. 2012. “Happiness as Surplus or Freely Available Energy, Psychology”, Scientific Research, Vol.3. No.9. [https://www.scirp.org/journal/PaperInformation.aspx?PaperID=22768].

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developed, further increasing the cost of the device. A vicious circle of unemployment and lower

income leading to financial barriers to access assistive devices to overcome environmental barriers,

which leads to lower likelihood of employment, has trapped persons with disability and also

households with disability. Those left without assistive devices, or with old-fashioned and

inefficient devices, are the target for those who enter the market with ‘low cost’ devices of dubious

scientific or medical value and poor regulatory compliance.

Consider this: The only reason that the Jaipur Foot, admittedly inferior to today’s carbon fibre

foot prosthetics, continues to be popular is owing to its low cost. Anyone who can pay for or be

fortunate enough to receive an Ottobock Triton, an Echelon Endolite, or an INR 5.5 Lakh

Freedom Foot22 would not choose a Jaipur Foot. This brings into question whether the fact that

benefiting an estimated 1.55 million people with disabilities makes Jaipur Foot a ‘popular’

prosthetic. The indigenous design, first developed in 1968, was intended for ‘rural people’.

According to their website23, the Jaipur Foot was developed to meet the socio-cultural needs of

handicapped people in India—squatting, sitting cross-legged, walking on uneven terrain, working

in muddy fields, and walking without shoes. The then available European and U.S. versions, the

SACH and the Seattle Foot, could not provide the required dorsiflexion of the ankle to permit

these positions and movement. However, in the years since, top-range, state-of-the-art prosthetic

feet can provide more support and movement than the Jaipur Foot. Unfortunately, Indian writers

on prosthetics continue to promote the Jaipur Foot as the best option on the ground of its low

cost. A 2018 U.S. review24 of commonly used prosthetic feet in developing countries found that

only the Niagara Foot and the ‘Shape and Roll (S&R)’ Foot have passed ISO-10328 testing.

Despite its long lifespan (2-5 years), Jaipur Feet were found to undergo the greatest deformation,

which would result in early knee flexion during walking and knee collapse proximal to the knee

joint for amputees. Under-standardised production practices led to defective craftsmanship in

56 per cent of cases for the Jaipur Foot, including leg length asymmetries. Inadequate foot fitting

resulted in non-optimal walking and suspension. Over half the pain reported from use of Jaipur

foot was attributed to these errors. Only half the amputees were actually able to sit cross-legged

22 Singh, J. 2015. “Artificial reality”, DownToEarth, July 4. [http://www.downtoearth.org.in/news/artificial-reality--40337]. 23 Bhagwan Mahaveer Viklang Sahayata Samiti, Jaipur. 2016. “HOW WE DO-Technology”. [http://jaipurfoot.org/how_we_do/technology.html]. 24 Laferrier, J. Z. et. al. 2018. “A Review of Commonly Used Prosthetic Feet for Developing Countries: A call for Research and development”, Journal of Novel Physiotherapies, February 27. [https://www.omicsonline.org/open-access/a-review-of-commonly-used-prosthetic-feet-for-developing-countries-acall-for-research-and-development-2165-7025-1000380.pdf].

https://www.downtoearth.org.in/news/artificial-reality--40337http://jaipurfoot.org/how_we_do/technology.htmlhttps://www.thehinducentre.com/publications/policy-report/article25770317.ece/binary/a-review-of-commonly-used-prosthetic-feet-for-developing-countries-acall-for-research-and-development-2165-7025-1000380.pdfhttps://www.thehinducentre.com/publications/policy-report/article25770317.ece/binary/a-review-of-commonly-used-prosthetic-feet-for-developing-countries-acall-for-research-and-development-2165-7025-1000380.pdf


and approximately 60 per cent were able to squat. About 38 per cent users reported discomfort at

even low to moderate activity.

Further, in 1994, Dr B.N. Prasad, chief of Orthopaedics at the Nizam Institute of Medical Sciences

(NIMS), Hyderabad, visited the DRDO’s Composite Product Centre hoping to borrow missile

technology for correcting skeletal deformities in children25. This was followed by Kalam’s visit to

NIMS where he observed children with residual paralysis resulting from polio infection. The

children were using metal and leather orthoses that were first developed in the mid-19th Century,

each weighing up to 3 kg. Kalam was instrumental in encouraging development, at DRDO, of

polypropylene thermoformed Floor Reaction Orthoses (FRO) weighing about 300 gm. It is

important to note that flexible plastic shell-type orthoses made of polypropylene were first

introduced around 197026 and thermoformed orthoses were in use since the 1960s27. The product

was manufactured and marketed by Artificial Limb Manufacturing Corporation of India

(ALIMCO). The calipers were in modular form and available in various sizes.

The astoundingly poor engineering design and outcome were far below the state-of-the-art even

by the standards of 1994. In 1989, Blatchford had come up with a custom fitted lightweight

modular orthosis for use in the early stages of rehabilitation. The orthoses industry was aware as

early as the mid-18th century that orthoses must be created specifically to cater to the persons’ size,

weight, and particular orthotic condition and movement constraints for the best outcome. The

leather and metal braces of earlier times were customised or custom-made for persons with

disability based on a prescription. Today, manufacturing and fitting the appropriate orthoses are a

product-and-service domain. The manufacturer and the orthotic specialist focus on fusing the

custom-made physical product with accompanying services and monitoring to enable the customer

to benefit from longer lasting, better fit, and comfort. Instead of undertaking the engineering,

design, and customisation work required, the project designed a single piece product of standard

sizes and modular components to allow for basic fitting. Such orthoses are currently used to help

clinicians identify and prescribe the right orthoses for their patients. Yet again, it was the argument

that the device was ‘low cost’, which, apart from the brand value of the DRDO and Kalam, allowed

25 Menon, A. K. 1994. “Spin-offs from defence technology help polio victims”, India Today, July 15. [https://www.indiatoday.in/magazine/indiascope/story/19940715-spin-offs-from-defence-technology-help-polio-victims-809390-1994-07-15]. 26 Showers, D. C and Strunck, M. L. 1984. “Sheet Plastics and Their Applications in Orthotics and Prosthetics”, Digital Resource Foundation for the Orthotics & Prosthetics Community, Vol. 38, Issue. 4, Pg. 41-48. [http://www.oandplibrary.org/op/1984_04_041.asp]. 27 Ibid.

https://www.indiatoday.in/magazine/indiascope/story/19940715-spin-offs-from-defence-technology-help-polio-victims-809390-1994-07-15http://www.oandplibrary.org/op/1984_04_041.asp


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extensive and unregulated use of the device. The devices were used by an estimated 50,000 people

with disabilities. According to reports, ALIMCO has stopped manufacturing the devices as of

201328. It is suggested that better use of the funds could have been made if the devices had been

better designed and trialled as per regulatory standards. Another possible better outcome would

have been to enter into an agreement with companies providing standard equipment and devices

to import or manufacture under license in India. The license could have covered upgrades, spares,

and training in fitting and maintenance.

The World Health Organisation (WHO) defines assistive devices and technologies as those whose

primary purpose is to maintain or improve an individual’s functioning and independence to

facilitate participation and to enhance overall well-being29. They can also help prevent impairments

and secondary health conditions. Examples of assistive devices and technologies include

wheelchairs, prostheses, hearings aids, visual aids, and specialised computer software and hardware

that increase mobility, hearing, vision, or communication capacities. Developing useful and usable

assistive devices requires input from multiple disciplines and sectors, including involvement and

participation of persons with the specific disability that the team is working to support. The

rehabilitation engineering and assistive technology market is driven globally by government

initiatives, and national policies and programmes. Advancements in health care facilities and

awareness regarding assistive devices technologies in the relevant populations, supported by

technological advancement in many areas, including software, communications technologies, and

material sciences, push the pace of device development.

WHO Standards for Orthotics and Prosthetics30 point out the responsibility of states to promote

the use of prostheses and orthoses at a cost that is affordable to users or to the state. It recalls that

governments should assume a leading role for the governance of prosthetics and orthotics services

and should involve a range of stakeholders in planning, developing, and monitoring services. A

guiding framework, consisting of legal acts, policies, strategic plans, standards, rules, and

regulations should be in place to guide the design of affordable, accessible, effective, efficient, and

safe services of high quality. Products and working methods should be appropriate to the setting

28 Krishan, S. R. 2015. “No takers for Kalam’s low priced stents”, The Sunday Guardian, August 1. [http://www.sunday-guardian.com/news/no-takers-for-kalams-low-priced-stents]. 29 World Health Organization. 2018. “Disability and rehabilitation: Assistive devices and technologies”. [http://www.who.int/disabilities/technology/en/]. 30 World Health Organization. 2017. “Standards for Prosthetics and Orthotics, Part 1: Standards”. [http://apps.who.int/iris/bitstream/handle/10665/259209/9789241512480-part1-eng.pdf;jsessionid=C664D1DDFC7934C23F44E800D622F421?sequence=1, 2017].

http://www.sunday-guardian.com/news/no-takers-for-kalams-low-priced-stentshttps://www.who.int/disabilities/technology/en/https://www.thehinducentre.com/publications/policy-report/article25770382.ece/binary/9789241512480-part1-eng.pdf


in which the products are fabricated, fitted, used, and funded. A national list of priority products

should be made, which would help to mobilise resources, guide product development, and

simulate competition. India, like many other countries, does not have national prosthetics or

orthotics standards. The WHO insists that state regulation is central to increasing access to safe,

effective, high-quality prostheses and orthoses. As these are health products, a regulatory system

is best established as an integral part of national health care regulation. The recommended

standards are ISO or equivalent structural requirements for testing of strength, durability, and

safety, and clinical field tests to ensure fitness for the purpose. Scientific testing methods are

recommended for reliability, validity, and comparability of results globally. A part of the standards

cover implementation and cast a duty on the governments to ensure that prosthetics and orthotics

services are provided only by qualified providers. Significantly, the WHO introduces the concept

of cost-effectiveness, which is ‘a measure of responsible use of the available funds…Efficiency is,

therefore, necessary for equity in service delivery’. The WHO advocates that various cost-sharing

arrangements should be put in place, including social insurance and cost proportional to amount

of care consumed.

India has not developed standards in the area of product or services relating to prosthetics and

orthotics. Many organisations—private/public, entrepreneurial, and social entrepreneurial—are

developing technology solutions through sponsored or self-funded research in rehabilitation

engineering and assistive devices. Collaborations such as SAATH (Seamless Affordable Assistive

Technology for Health) are also emerging. SAATH is a collaboration between IIT Kanpur, IISc

Bangalore, KTH Sweden, and Gavle University, involved in developing physical activity monitory

and diagnostic tools for assessing the mobility and motor skills of elderly persons. The TTK Centre

for Rehabilitation Research and Device Development Lab (R2D2) is a TTK Health Care

supported lab at IIT Madras. The group is involved in research related to human movement, the

influence of orthotic and prosthetic devices on movement, and in the design and development of

assistive devices for persons with impairments. Start-ups are enthusiastically attempting to convert

good intentions and technological competence into sector specific assistive devices—Tellmate, a

pair of wearable glasses that process images, convert them into sound, and whisper it into the ear

using hearing aids; Braille Me, an input-output device where content can be read and typed, and

FJ Typer, which is a training tool to help children with poor vision31.

31 Mandavia, M. 2017. “How a bunch of Indian tech startups hope to change the world for the visually impaired”, The Economic Times, June 12. [https://economictimes.indiatimes.com/small-biz/startups/fledgling-assistive-technology-space-gets-help-from-startups/articleshow/59100127.cms].

https://economictimes.indiatimes.com/small-biz/startups/fledgling-assistive-technology-space-gets-help-from-startups/articleshow/59100127.cms


11

However, in general, Indian innovators in assistive device technology lack crucial understanding

of the market realities. It appears that innovators have, at best, a rather sketchy understanding of

issues like freedom-to-operate and infringement of Intellectual Property Rights (IPR), regulatory

and industry standards and the necessity to comply with them, and the need for robustness,

precision, accuracy and reliability for use by the disability sector. Yet, these projects also win awards

and funding from public and private bodies and programmes, such as the DST-Lockheed Martin

India Innovation Growth Programme (IIGP), the Wellcome Trust, and the state and central

governments. As an underserved and under-supported sector, the assistive devices sector only

benefits from innovations by those innovators who have spotted the niche funding opportunity

and lack of robust competition in the so-called low cost indigenous market.

On a random selection, this Report selected Tellmate—the wearable glasses that convert visual

image to speech. The project won the 2016 DST-Lockheed Martin IIGP Award and benefited

from some INR 25-50 Lakhs worth of funding for development of the project and an incubation

opportunity at IIM Ahmedabad. Their page inviting interns32 helpfully informs candidates that

Tellmate Helper Private Limited is today a DIPP-recognised start-up and has won the MEA-NITI

Aayog Contest on social innovation and was also featured on Mann Ki Baat. Their latest version is

available as a smartphone app, which appears to have the ability to take pictures using a mobile

phone camera, crop the image to focus on specific text/image, upload the selected content to their

server, and receive the synthesised content in speech format. It requires great precision in taking

the appropriate photograph, cropping/editing it to the required focus area, and waiting for the

server to respond.

In essence, the technology is a software application—an app—that is built of components such as

mobile optical character recognition (OCR) that enable on-the-go access to printed documents

such as restaurant menus, bills, or signs on walls. The efficiency of the outcome is driven by the

processing power of smartphones, the imaging characteristics and the high resolution of phone

cameras, and the maturity of OCR algorithms. The limitations of OCR for use in assistive devices

is the requirement of a well-framed image of the text at good resolution—poor resolution, wrong

angle of orientation of the camera or camera phone, and writing that is not clean/crisp text could

reduce the usability of the technology with persons with visual impairment. Persons unable to see

the mobile screen or unable to hold the mobile steady would not be able to capture a good picture

32 Internshala. 2018. “Embedded Systems Internship in Jaipur at Tellmate Helper Private Limited”. [https://internshala.com/internship/detail/embedded-systems-internship-in-jaipur-at-tellmate-helper-private-limited1521311103].

https://internshala.com/internship/detail/embedded-systems-internship-in-jaipur-at-tellmate-helper-private-limited1521311103


for processing. Some accessibility apps like Text Detective capture images continuously and

process the readable text as soon as it is detected33. Tellmate is impaired by these limitations of

over-the-counter technology components and their rate of interoperability. For instance, while

comparable apps like Text Detective require no internet connection and process the image using

the phone’s processing capacity, Tellmate requires the text to be uploaded to a server for

processing. The technology components are free for download for developers and are provided

under an End User License Agreement (EULA) that have different license agreements for product

commercialisation or may be covered under licenses that require the product to be used in

conjunction with specific platforms.

In any case, those interested in such a pair of miracle glasses as attempted by Tellmate could try

the US$ 3500 OrCam MyEye, a breakthrough wearable artificial vision device, which is a tiny

lightweight camera mounted on a pair of glasses that can intuitively, instantly, and discreetly read

printed text and digital text aloud, and interpret faces, currency notes, and products (using a

database of barcodes). OrCam understands gestures and is triggered by a simple pointing gesture.

The OrCam wearable is built by the founders of Mobileye—pioneers in autonomous cars—

subsequently acquired by Intel. The OrCam patent34, filed in 2012, covers a visual assistance device

wearable by a person that includes a camera and a processor. The processor captures multiple

image frames from the camera. A candidate image of an object is searched in the image frames,

classified as an image of a particular object or in a particular class of objects, and is thereby

recognised. The person is notified of an attribute related to the object. OrCam is also the assignee

of the gestural interface invention of Pranav Mistry and Patricia Maes, of the MIT Media Lab. The

MIT Media Lab is at the forefront of wearable computing, wireless communications, machines

with common sense, and learning technologies. The technology recognises gestures, including

pointing at objects in the users’ environment and interacting with graphical interfaces.35

The illustration demonstrates that technology dependence is determined by those in control over

Intellectual Property assets. The platform dependency of devices ensures that the company that

owns software platform and the hardware ensures that products cannot be sold without the

intellectual property value being repatriated to the companies that own them. Costing then,

33 iaccessibility.com. “Text Detective”. [https://www.iaccessibility.com/apps/low-vision/index.cgi/product?ID=60]. 34 Espacenet Patent search. “Bibliographic data: EP2490155 (A1) ― 2012-08-22”. [https://worldwide.espacenet.com/publicationDetails/biblio?CC=EP&NR=2490155A1&KC=A1&FT=D]. 35 IFI Claims Patent Services. 2009. “Wearable Gestural Interface”, February 3. [https://patents.google.com/patent/US20100199232A1/en].

https://www.iaccessibility.com/apps/low-vision/index.cgi/product?ID=60https://worldwide.espacenet.com/publicationDetails/biblio?CC=EP&NR=2490155A1&KC=A1&FT=Dhttps://patents.google.com/patent/US20100199232A1/en


13

according to the WHO standards, can be reduced significantly by some government steps

such as reducing/waiving import taxes on components, materials, tools, machines and other

equipment, and inclusion of services to support early detection, early treatment, and prevention of

secondary impairments.

The global elderly and disabled assistive devices market36 is fragmented with high competition

among the players. In spite of this, the market is predicted to touch US$ 19,684.9 million in 201937

and US$ 26 billion by 202438. The wheelchair market, under medical mobility aids and ambulatory

devices, is in a dominant position. Geographically, the U.S. leads the market owing to the fact that

numerous market players are based in the U.S. On the other hand, a number of Asian countries,

such as China, India, and Japan, will be experiencing the most exponential development in the

market in the coming years due to rising disposable incomes and increasing healthcare reforms in

these countries. The Asia Pacific elderly and disabled assistive devices market is predicted to touch

US$ 5,051.1 million by 2019. According to The Times of India, the market size for assistive devices

in India is about INR 4,500 crores39.

A 2014 Infosys report40 states that the Indian medical device industry is replete with challenges,

including archaic regulatory standards, inadequate quality standards and non-compliance, high

import dependency, meagre government funding to promote innovation, and lack of local talent.

As much as 75 per cent of India’s total demand for medical devices is currently met by imports,

with nearly 30 per cent being supplied by the U.S. alone. As the U.S. is a leader in medical device

innovation, there is a mismatch between the design of certain technologies being imported and

the realities of clinical conditions and health care infrastructure existing in India.

36 Transparency Market Research. 2016. “Global Elderly and Disabled Assistive Devices Market: Wheelchairs Spend in U.S. is Highest Globally” October. [https://www.transparencymarketresearch.com/pressrelease/elderly-disabled-assistive-devices-industry.htm]. 37 PR Newswire. 2014. “Elderly And Disabled Assistive Devices Market - Global Industry Analysis, Size, Share, Growth, Trends & Forecast to 2019”, April 25. [https://www.prnewswire.com/news-releases/elderly-and-disabled-assistive-devices-market---global-industry-analysis-size-share-growth-trends--forecast-to-2019-256673091.html]. 38 McCue, TJ. 2017. “Elderly And Disabled Assistive Technology Market To Surpass $26 Billion By 2024”, Forbes, March 21. [https://www.forbes.com/sites/tjmccue/2017/03/21/elderly-and-disabled-assistive-technology-market-to-surpass-26-billion-by-2024/#3e33277969ea]. 39 Debroy, S. 2016. “Market size of assistive technology for persons with disabil ity is Rs 4500 crore”, The Times of India, February 20. [https://timesofindia.indiatimes.com/business/india-business/Market-size-of-assistive-technology-for-persons-with-disability-is-Rs-4500-crore/articleshow/51062327.cms]. 40 Peter, D. “Indian Medical Device Industry – Current State & Opportunities for Growth”, Life Sciences and Services, Infosys Consulting. [https://www.infosys.com/consulting/insights/Documents/indian-medical-device-industry.pdf].

https://www.transparencymarketresearch.com/pressrelease/elderly-disabled-assistive-devices-industry.htmhttps://www.transparencymarketresearch.com/pressrelease/elderly-disabled-assistive-devices-industry.htmhttps://www.prnewswire.com/news-releases/elderly-and-disabled-assistive-devices-market---global-industry-analysis-size-share-growth-trends--forecast-to-2019-256673091.htmlhttps://www.prnewswire.com/news-releases/elderly-and-disabled-assistive-devices-market---global-industry-analysis-size-share-growth-trends--forecast-to-2019-256673091.htmlhttps://www.forbes.com/sites/tjmccue/2017/03/21/elderly-and-disabled-assistive-technology-market-to-surpass-26-billion-by-2024/#3e33277969eahttps://timesofindia.indiatimes.com/business/india-business/Market-size-of-assistive-technology-for-persons-with-disability-is-Rs-4500-crore/articleshow/51062327.cmshttps://www.thehinducentre.com/publications/policy-report/article25770452.ece/binary/indian-medical-device-industry.pdf


The Emerging Ecosystem for Assistive Devices in India

Three recent legal instruments are set to alter the assistive devices scene in India. The instruments,

arriving nearly together set up formidable barriers to poor research and engineering, and non-

standard assistive devices being distributed to unwary persons with disability who are in want and

discomfort. These are:

a. The Rights of Persons with Disability (RPWD) Act, 2016

The RPWD Act, 2016, is an Indian enactment to give effect to the UN Convention on the Rights

of Persons with Disabilities (UN CRPD). The CRPD is an international human rights treaty of the

United Nations intended to protect the rights and dignity of persons with disabilities. Parties to

the Convention are required to promote, protect, and ensure the full enjoyment of human rights

by persons with disabilities and ensure that they enjoy full equality under the law. The Convention

has served as the major catalyst in the global movement: It has been instrumental in bringing about

a change perspective, from viewing of persons with disabilities as objects of charity, medical

treatment, and social protection to viewing them as full and equal members of society, with human

rights who are capable of claiming those rights and making decisions for their lives based on their

free and informed consent as well as being active members of society. To date, 177 countries,

including India, have ratified the treaty. The treaty also provides a framework for inclusion of the

Sustainable Development Goals. The 2030 Agenda for Sustainable Development clearly states that

disability cannot be a reason or criteria for lack of access to development programming and

realisation of human rights. The Sustainable Development Goals framework includes seven

targets, which explicitly refer to persons with disabilities, six further targets on persons in

vulnerable situations, which include persons with disabilities.

The RPWD Act protects persons with disabilities from being included as participants in trials

without the permission for the Committee on Research on Disability and without written informed

consent for participation. The Act urges respect for difference and acceptance of persons with

disabilities as part of human diversity and humanity towards full and effective participation and

inclusion in society. Government focus is driven towards universal design of built environment

and consumer products, including electronics. Reasonable accommodation is to be provided by

employers and government institutions are required to support and enable persons with high

support needs to live independent and full lives.


15

b. The Medical Devices Rules, 2017

The Medical Device Rules, 2017, came into effect on January 1, 2018. The Rules have been

framed in conformity with the Global Harmonisation Task Force Framework and conform to the

best international regulatory practices to meet the requirement of the medical devices sector.

Medical devices, classified according to risk category, will be required to meet proportionate

regulatory requirements. The Rules also seek to evolve a culture of self-compliance by

manufacturers through self-certification and post-approval audits. The Rules provide for separate

regulations for clinical trials of investigational devices on par with international practices, to be

regulated by the Central Drugs Standard Control Organisation. Trials are required to be conducted

in a manner that helps realise the goals of both safety and welfare, and discovery and

commercialisation of new devices. Medical management and compensation are provided for in the

case of unexpected adverse events. The Rules seek to enable the creation of a robust ecosystem

for all stakeholders, including innovators, manufacturers, providers, consumers, buyers, and

regulators. Ambitiously, the Health Ministry expects the Rules to foster India-specific innovation

and improving accessibility and affordability of medical devices across the globe by leveraging cost

advantage of manufacturing in India.

c. The National Ethical Guidelines for Biomedical and Health Research Involving

Human Participants, 2017

These guidelines, published by the Indian Council for Medical Research (ICMR), cover important

areas of biomedical research and research involving human participants, including responsible

conduct of research, informed consent process, vulnerability, biological materials, and research

during humanitarian emergencies and disasters. The guidelines comprehend and attempt to

address the socio-cultural ethos in India and the varying standards of healthcare while being

sensitive to the social and natural environment. Expanding on the principles of non-maleficence,

autonomy, beneficence, and justice, the guidelines enable researchers and sponsors to ensure that

research and scientific experimentation are conducive and consistent with the dignity and well-

being of participants. The guidelines also invite the participant to meaningfully engage with the

community before, during, and after research to ensure greater responsiveness to their health needs

and requirements. The scientist is required to be a responsible member of society and should

ensure the protection of human and animal participants. The guidelines also provide extensive

guidance on the formation and functioning of ethics committees, including the different types of

review processes and management of adverse events.


Trial ethics are in an advanced stage of evolution globally. Many processes and protocols have

been accepted as best practice. In India, testing of technology solutions for disabled persons need

to be advanced significantly to bring it in alignment with globally acceptable standards (if not best

practice) for such trials. With the growing interest in rehabilitation engineering and assistive

technology devices among commercial groups such as TTK Healthcare, Appasamy Associates,

Trivitron Healthcare, Aurolab—a division of Aravind Eye Care—and Wipro and others, trial

ethics and responsible conduct of research becomes an important indicator of the commercial

strategy and intent of the companies. On the other hand, failure to adhere to the regulatory

requirements could lead to onerous liabilities, including imprisonment, fines and loss of reputation.

This study is intended to identify the gaps and irregularities in the current research and trial

ecosystem and shed light on the intersection of the new legal instruments set to alter the research

ecosystem in India.


17

II. CLINICAL TRIAL OF MEDICAL DEVICES IN INDIA

he Drugs and Cosmetics Act, 1940, regulates the import, manufacture, distribution and

sale of drugs and cosmetics. Under the Act, the term ‘drug’ includes such devices

intended for internal or external use in the diagnosis, treatment, mitigation, or

prevention of disease or disorder in human beings or animals, as may be specified from time to

time by the Central Government41 after consultation with the Drugs Technical Advisory Board42.

Notified devices (about 50) require registration before they can be sold in India. For other medical

devices that do not require registration, the manufacturer can obtain a No Objection Certificate

(NOC) from the Drug Controller General of India (DCGI). Foreign clinical data or testing reports

may be considered to be sufficient for registration in certain cases; in other cases, the DCGI may

require a clinical trial to be conducted in India in respect of the device.

Prior to 2005, no medical device regulations existed in India. Subsequently, the Central Drugs

Standard Control Organisation (Medical Devices Division), on August 4, 2010, issued a Guidance

Document on Requirements for Conducting Clinical Trial(s) of Medical Devices in India. Again,

on July 12, 2016, the Ministry of Health and Family Welfare released a Draft Medical Device Rules,

2016. Finally, in exercise of its powers under Section 12 and 33 of the Drugs and Cosmetic Act,

the Union Ministry of Health and Family Welfare notified the Medical Devices Rules, 2017, by

notification dated January 31, 2017. The Rules came into effect on January 1, 2018.

The Rules introduce a new regulatory framework for clinical investigation of medical devices. The

Rules cover several important aspects of research on rehabilitative and assistive devices. They

provide helpful clarity in many areas that would ultimately help to improve outcomes in research

in rehabilitative and assistive devices. Under the 2017 Rules, medical devices mean:

a. Specific devices intended for internal or external use in the diagnosis, treatment, mitigation

or prevention of disease or disorder in human beings or animals which are notified by the

government from the time to time under the Drugs and Cosmetics Act, 1940 (“D&C Act”).

Some categories of devices have already been notified by the government. A list of classes

of currently notified medical devices is annexed as Annexure D;

41 Section 3(b)(iv); Under Rule 3(zb) of the Medical Device Rules, 2017, a ‘medical device’ means (C) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act. 42 Constituted under Section 5.

T


b. Specific substances intended to affect the structure or any function of the human body

which are notified by the government. At present, the substances notified are mechanical

contraceptives (eg. condoms, intrauterine devices, tubal rings) and disinfectants;

c. Surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and

blood component collection bag with or without anticoagulant;

d. Substances used for in vitro diagnosis (referred to in the 2017 Rules as “In Vitro Diagnostic

Medical Device”);

e. All substances intended to be used for or in the diagnosis, treatment, mitigation or

prevention of any disease or disorder in human beings or animals. This is a catch-all

category for substances.

Only products that are covered by the definition of medical devices will be regulated by the 2017

Rules. A fixed timeline of 90 days has been prescribed for the licensing authority to arrive at a

decision on application for permission to conduct clinical trial. Rule 3(a) defines ‘academic clinical

study’ as a clinical study conducted for academic purpose on a medical device for

1. the approved or a new intended use,

2. new material or construction,

3. new improved design or

4. new population.

Interpretation of ‘academic clinical study’, as any clinical study undertaken towards the earning of

a higher degree, or for a formal purpose, is erroneous. In fact, if towards the earning of a degree,

a student undertakes clinical study that goes beyond the definition in section 3(a), it would not be

an academic clinical study. Design that shall affect the quality in respect of its specifications,

indication for use, performance, and stability of an approved medical device, is considered to be

major change. Rule 51(3) states that no permission for conduct of academic clinical study on

licensed medical device shall be required where the Ethics Committee has approved such a study

and where the data generated during the study shall not be used to furnish to the Central Licensing

Authority to manufacture or to import for marketing any investigational medical device in the

country.

Before a device can be marketed for use by the general population in India, the CDSCO must

approve it for use. To obtain this approval a device must undergo clinical investigation—a


19

systematic study of the investigational device in or on human participants to assess its safety,

performance, or effectiveness43. There must be clinical evidence to support the scientific validity

and performance for the intended use of the device. This includes clinical data—the safety and/or

performance information that is generated from the clinical use of the device. Clinical performance

is the behaviour of a medical device or response of the subjects to that medical device in relation

to its intended use44, when correctly applied to appropriate patients.

Clinical data is collected from various sources:

1. clinical investigations of the investigational device;

2. other studies reported in scientific literature;

3. data relating to a similar device for which equivalence to the investigational device can be

demonstrated;

4. published and/or unpublished reports on other clinical experience of either the

investigational device or similar device for which equivalence to the investigational device

can be demonstrated.

Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise, and analyse

clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical

evidence to confirm compliance with relevant essential requirements for safety and performance

when using the device according to the manufacturer’s Instructions for use.

Assistive and rehabilitative devices are covered under the definition of ‘active therapeutic devices’45

in the Medical Devices Rules, 2017. The definition covers active medical devices, whether alone

or in combination with any other medical device, to support, modify, replace, or restore biological

functions or structures, with a view to the treatment or alleviation of any illness, injury, or handicap.

Active medical devices are defined as medical devices that depend on a source of electrical energy

or any other source of energy other than the energy generated by human or animal body or gravity.

43 Rule 3(l). Under section 3(x) an investigational medical device is a device which does not have a predicate device, or one which is licensed for new use or new population, or major design change, and is being assessed for safety, performance or effectiveness. A predicated device (Rule 3(zm)) means a device, the first of its kind approved for manufacture for sale or for import by the CDSCO and has the similar intended use, material of construction, and design characteristics as the device which proposed for licence in India. 44 ‘Intended use’ as per Rule 3(v) means the use for which the medical device is intended according to the data supplied by the manufacturer on the labelling or in the document containing instructions for use of such device or in promotional material relating to such device, which is as per approval obtained from the Central Licensing Authority. 45 Rule 3(e).


Most assistive and rehabilitative devices, when mass produced, require ‘setting up’ of the device

for specific body and overall condition of the user. For instance, a device such as crutches, if placed

too low for body height, will result in excessive stress on the upper extremities; if placed too high,

it would result in shoulder discomfort. Sometimes, an assistive or rehabilitative device may have

to be ‘custom made’ in accordance with a written prescription of a registered medical practitioner

for the sole use of a particular patient46. Research in custom made devices require a prescription

for the device to be used for a particular patient.

Classification of Devices

In tune with the global practice, the 2017 Rules will introduce a risked based classification system

for regulation of medical devices. Rule 4 classifies devices as

(i) low risk - Class A;

(ii) low-moderate risk- Class B;

(iii) moderate-high risk- Class C;

(iv) high risk- Class D.

The classification is based on parameters specified in Part I of the First Schedule. Assistive devices

that are non-invasive and come into contact with intact skin only are classified as Class A devices.

Active devices would be classified as Class B. A long-term use medical device is assigned to Class

D if it is an active medical device. Long-term use is defined as intended continuous use of the

medical device for more than 30 days. According to Rule 7, the device shall conform to the

standards laid down by the Bureau of Indian Standards or as may be notified by the Ministry of

Health and Family Welfare, Government of India. Where no relevant standard of any medical

device has been laid down, the device shall conform to the standard laid down by the International

Organisation for Standardisation (ISO) or the International Electro Technical Commission (IEC)

or by any other pharmacopoeial standards. If the standards have not been specified, the device

shall conform to the validated manufacturer’s standards.

Rule 93(1) prescribes debarment on account of submission of misleading information along with

an application for grant of any license; the knowledge or intention of the applicant to mislead the

authority is irrelevant. In order to comply with the regulatory requirements pertaining to clinical

46 A ‘custom made medical device’ as per Rule 3(r) is a medical device made specifically in accordance with a written prescription of a registered medical practitioner, specialized in the relevant area, under his responsibility for the sole use of a particular patient, but does not include a mass production of such device.


21

trials, the investigator and the sponsor or institution must maintain and store documents and

content related to the trial. While some countries require the maintenance of a Trial Master File

(TMF), India has no specific requirement. The investigator is, however, required to maintain

essential documents that enable the conduct of a trial and evaluation of the data produced.

Licenses granted under the Device Rules are perpetual, meaning that they will continue to be valid

unless cancelled. When applying for a licence to import, manufacture, sell, or distribute a Class A

device, the applicant must submit the following documents:

1. Device description, intended use of the device, specification including variants and

accessories;

2. Material of construction;

3. Working principle and use of a novel technology [if any];

4. Labels, package inserts, user manual, wherever applicable;

5. Summary of any reported Serious Adverse Event in India or in any of the countries where

device is marketed and action taken by the manufacturer and National Regulatory Authority

concerned;

6. Site or plant master file as specified in Appendix I of the Fourth Schedule;

7. Constitution details of the firm [of domestic manufacturer or authorised agent];

8. Essential principles checklist for demonstrating conformity to the essential principles of

safety and performance of the medical device;

9. Undertaking signed by the manufacturer stating that the manufacturing site is in compliance

with the provisions of the fifth schedule.

In the case of the Class B device, the device master file must also be provided in addition to other

information. The site or plant master file must contain, inter alia, general information on the use of

outside scientific, analytical or other technical assistance in relation to the design, manufacture and

testing, and a short description of the quality management system of the company. With regard to

equipment, description is required as to the qualification and alliteration, including the recording

system, and arrangements for computerised systems validation. The description of arrangements

for the handling of complaints and for the handling of field safety corrective action is also required

to be provided. All devices approved for sale in India must be accompanied by a Declaration of

Conformity, including details of applicable safety directives the product complies with and details

of relevant standards. A Design dossier that includes detailed information about the design,


function, composition, use, claims, and clinical evaluation of the device is also required for

registration of a Class B device.

Product specification dossier with that must contain, inter alia, the intended population and medical

condition, description of the accessories, configurations and variants, and its functionality. An

explanation of any novel features is to be included. Labelled pictorial representations—diagrams

photographs and drawings—clearly indicating key parts or components, including sufficient

explanation to understand the drawings and diagrams, should be included. Performance attributes

should also be included. The dossier should contain enough information to allow the reviewer to

obtain a general understanding of the device.

The verification and validation of the medical device should include information covering

a) Engineering tests;

b) Laboratory tests;

c) Simulated use testing;

d) Any animal tests demonstrating feasibility of proof of concept of the finished device; and

e) Any published literature regarding the device or substantially similar devices.

The summary information may include a declaration or certificate of conformity to a recognised

standard and summary of the data if no acceptance criteria is specified in the standard. A

declaration or certificate of conformity is to be provided to a professional guideline, industry

method, or in-house test method, supported by a rationale for its use. Detailed biocompatibility

study data as prescribed standards and software verification and validation should be provided in

addition to clinical evidence.

Where there is no predicate device, additional data is to be provided, including mechanical and

electrical tests, reliability tests, risk management data, proposed instructions for use, design input,

and device specification, including specificity, sensitivity, reproducibility, and reputability. Design

input means the physical and performance requirements of the device that are used as the basis

for device design.

The product dossier must also contain the product specification—any requirement with which a

product, process, service, or other activity to which the product must conform—and the methods


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needed to identify the processes for quality management and how the processes may be monitored,

measured, and analysed. The application form for regulatory approval from the device

manufacturer should include description of the document management system. A documented

procedure for design and development shall be set in place, and the process of control of design

and development, as well as the processes of review, verification, validation, and design transfer,

shall be included in the documentation submitted to the regulatory authority.

Clinical Investigation

Clinical investigation is covered under Para 2 of the Seventh Schedule of the Medical Devices

Rules, 2017. Clinical investigation on an investigational medical device can only be initiated after

approval has been has been obtained from a registered ethics committee47. As of April 1, 2018, the

Clinical Trials Registry–India, CTRI, accepts and registers trials only prospectively; therefore,

investigators whose proposals have been approved by the ethics committee must register with the

CTRI before the enrollment of the first participant.

The investigator should possess appropriate qualification, training, and experience, and should

have access to such investigational and treatment facilities as are relevant to the proposed clinical

investigation. A qualified physician who is a sub-investigator for the investigation shall be

responsible for all investigation-related decisions concerning medical issues. Laboratories used for

generating data for clinical investigation should be compliant with Good Laboratory Practices

(GLP) or should have accreditation certificate issued by the National Accreditation Board for

Testing and Calibration of Laboratories. According to Rule 58 of the Medical Device Rules, the

sponsor and any other organisation or investigator shall disclose to the Medical Device Officer or

any other officer authorised by the Central Licensing Authority the names, addresses and other

particulars of persons involved in the clinical investigation. Any change of investigation plan

should be implemented only after approval of the Ethics Committee and the Licensing Authority.

The sponsor is responsible for implementing and maintaining quality assurance system to ensure

that the clinical investigation is designed, conducted, monitored and that the data is generated,

documented, recorded, and reported in compliance with clinical investigational plan and Good

Clinical Practices Guidelines issued by the CDSCO. The sponsor is also required to submit a status

report on the Clinical Investigation to the Central Licensing Authority at the prescribed periodicity,

including safety summary and deviations.

47 Registered under rule 122DD of Drugs and Cosmetics Rules, 1945.


It is the duty of the sponsor to report any adverse event or serious adverse event to the Chairman

of the Ethics Committee, Central Licensing Authority, and the head of the institution where the

clinical investigation has been conducted within 14 days from the knowledge of the occurrence.

In case of injury or death, the sponsor shall make payment for medical management of the subject

and also provide financial compensation for clinical investigation related injury or death in the

manner specified in the Drugs and Cosmetics Rules. The sponsor is also required to provide the

clinical investigation report, whether for a completed or prematurely terminated investigation, to

the Ethics Committee, participating investigators, and the Central Licensing Authority. In case the

sponsor wishes to prematurely discontinue the investigation for want of commercial interest, he

must inform the Central Licensing Authority and also submit a summary report within a period of

ninety days having a description of the investigation, the number of patients exposed to the

investigational medical device, details of adverse device affect or serious adverse event,

compensation paid, if any, and the reason for discontinuation of the investigation or non-pursuit

of the investigational medical device application.

The Investigator is responsible for the conduct of the investigation in accordance with his

undertaking to adhere to

clinical investigation plan

GCP guidelines

Standard operating procedures are required to be documented by the investigators for the tasks

performed by them. During and following a subject’s participation in an investigation, the

investigator should ensure that adequate medical care is provided to the participant for any adverse

events. The investigator shall report all serious adverse events to the Central Licensing Authority,

sponsor, and the Ethics Committee within 48 hours of the occurrence. In case the investigator

fails to report any serious adverse event within the stipulated period, he shall have to furnish the

reason for the delay to the Central Licensing Authority along with the report of the serious adverse

event. The detailed report, after due analysis, shall be forwarded by the investigator to the

Chairman of the Ethics Committee, the Central Licensing Authority, and the head of the

institution where the investigation has been conducted, within fourteen days of occurrence.


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The investigator shall provide information to the clinical investigation subject through informed

consent process as provided in the Rules about the essential elements of the clinical investigation

and the subject’s right to claim compensation in case of investigation-related injury or death. He

shall also inform the subject or his/her nominee of their rights to contact the sponsor or his

representative for making claims in case of investigation-related injury or death.

It is the responsibility of the Ethics Committee to safeguard the rights, safety, and well-being of

all study subjects. The committee should exercise particular care to protect the rights, safety, and

well-being of all study subjects. The Ethics Committee should exercise particular care to protect

the rights, safety, and well-being of all vulnerable subjects participating in the study. The vulnerable

subject, according to the explanation, are members of a group with hierarchical structure, patients

with incurable diseases, unemployed or impoverished persons, patients in emergency situation,

ethnic minority groups, homeless persons, nomads, refugees, minors and other persons incapable

of personally giving consent. Ethics committees must have documented Standard Operating

Procedures and should maintain a record of its proceedings. The committee should undertake

ongoing review of approved projects based on periodic study progress reports furnished by

investigators or monitoring and internal audit reports of the sponsor. In case an Ethics Committee

revokes site approval, it shall record reasons for doing so and, at once, communicate such a

decision to the investigator as well as to the Central Licensing Authority. Any report of serious

adverse event, after due analysis, shall be forwarded by the Chairman of the Ethics Committee to

the Central Licensing Authority and to the head of the institution where the clinical investigation

has been conducted, within 14 days of the knowledge of occurrence of the serious adverse event.

Sub para 5 of Para 2 of the Seventh Scheduled covers Informed Consent. In all investigations, a

freely given informed written consent is required to be obtained from each study subject. The

investigator shall provide information about the study verbally and through the patient information

sheet in a language that is non-technical and is understandable by the study subject. The subjects’

consent must be obtained in writing using an ‘Informed Consent Form’. The patient information

sheet as well as the Informed Consent Form shall be approved by the Ethics Committee and

furnished to the Central Licensing Authority. Any change in the informed consent documents

should be approved by the Ethics Committee and submitted to the Central Licensing Authority

before such changes are implemented.


Where a subject is not able to give informed consent, e.g. an unconscious person, or person

suffering from severe mental illness or disability, the same may be obtained from a legally

acceptable representative. If the subject or his legally acceptable representative is unable to read or

write, an impartial witness should be present during the entire informed consent process who

must append his signature to the consent form. A legally acceptable representative means a person

who is able to give consent or authorise an intervention in the patient as provided by the law in

India. The informed consent process, in case of vulnerable subjects in clinical investigations

of an innovative medical device which is not approved anywhere in the world, shall be

audio-video recorded.

Types of Investigation

The rules contemplate different types of investigation:

Pilot Clinical Investigation

A pilot clinical investigation is defined as those clinical investigations that are used to acquire

specific essential information about a device before beginning the pivotal clinical investigation. It

is an exploratory study that may be conducted on a few patients with the disease of condition

being studied before moving on to a large population and scope that give insight into the

performance and safety of a device but cannot provide definitive support for specific mechanistic

or therapeutic claims. The objectives of the pilot clinical investigation, including assessing

feasibility [preliminary device performance], exploring eligibility criteria, and a practical application

for pivotal controlled investigation, ascertaining potential harm [preliminary safety evaluation],

studying device mechanism, validated a method for determining and outcome measure using a

defined device mechanism to validate a surrogate outcome measure and evaluating the logistics of

pivotal investigation for performance.

Pivotal Clinical Investigation

The pivotal clinical investigation is the definitive study in which evidence is gathered to support

the safety and effectiveness evaluation of the medical device for its intended use. Pivotal clinical

investigation is a confirmatory study that may be conducted on a large number of patients with

disease or condition being studied and offers a scope to provide the effectiveness and adverse

effects. For investigational Medical Devices that do not have a predicate medical device